title: Assuring the quality, safety, and efficacy of DNA vaccines.
abstract: Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. This chapter will provide an overview of the regulatory process and will discuss in more detail the quality and pre-clinical safety issues of plasmid DNA vaccines intended for human use. It is useful for research scientists to be aware of these processes as the development of a novel vaccine could be problematic due to the starting material often being developed in a research laboratory under ill-defined conditions.
authors.affiliation: National Institute for Biological Standards and Control, Hertfordshire, UK.
authors.forename: J S
authors.initials: JS
authors.lastname: Robertson
authors.forename: E
authors.initials: E
authors.lastname: Griffiths